Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy

The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01776489

Enrollment

Registered

2013-01-28

Start date

2011-12-31

Completion date

2017-01-31

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaphylaxis, Food Allergy

Keywords

Food allergy, Sphingosine-1-phosphate, Biomarker, Double-blind placebo-controlled food challenge, Anaphylaxis

Brief summary

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date. Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Months to 17 Years

Healthy volunteers

Inclusion criteria

* Patients between 1-17 years who have been reported to suffer from food allergic reactions and who are subjected to DBPCFC or open provocation * Patients who are diagnosed by elevated allergen specific IgE and/or positive skin prick testing * Willingness to participate in the study

Exclusion criteria

* Refusal to participate in the study * Non-IgE-mediated food allergy

Design outcomes

Primary

Measure	Time frame	Description
S1P in allergic and non-allergic patients before and after challenge	up to 3 years	The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.

Secondary

Measure	Time frame	Description
Evaluation of allergic mediators and correlation with S1P levels	up to 3 years	Evaluation of allergic mediators like histamine, human mast cell tryptase and eosinophil cationic protein and correlate these results with the levels of S1P within the group and between allergic and non-allergic patients

Countries

Austria

Contacts

Primary ContactZsolt Szépfalusi, MD

zsolt.szepfalusi@meduniwien.ac.at+43 1 40400

Backup ContactSusanne C. Diesner, MD, PhD

susanne.diesner@meduniwien.ac.at+43 1 40400

Outcome results